Use of an Oral Beta-2 Agonist in Persons With Spinal Cord Injury

A Randomized, Double-blind, Placebo-controlled Parallel Group Trial to Determine the Effect of an Oral Beta-2 Agonist on Respiratory Muscle Strength in Spinal Cord Injury

The primary purpose of this study is to determine the effect of administration of the oral beta-2 adrenergic agonist, albuterol, on respiratory muscle strength in individuals with cervical (neck) and high thoracic (upper back) spinal cord injury and to compare findings with those obtained in a demographically matched group that will receive placebo. Participation in this study will involve 12 weeks of pharmacological intervention during which participants will be randomized to receive either oral albuterol 4mg twice daily or placebo. All investigators and study participants will be blinded to randomization by our research pharmacy. Participation in the study will require study subjects to come to our lab for the total of 2 visits (at baseline and after week 12), during which a series of tests will be performed to assess their respiratory muscle strength and pulmonary function.

Study Overview

• Status: Completed
• Conditions: Spinal Cord Injury
• Intervention / Treatment: Drug: placebo; Drug: extended release beta-2 adrenergic agonist

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• United States
  • New York
    • Bronx, New York, United States, 10468
      • VA Medical Center, Bronx

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Chronic Spinal Cord Injury (>1 year post-injury)
• All American Spinal Injury Association (ASIA) classifications
• High Paraplegia (level of injury T1-T6)
• Tetraplegia (level of injury C2-C8, non-ventilator dependent)

Exclusion Criteria:

• history of asthma
• uncontrolled hypertension or cardiovascular disease
• those using beta-2 adrenergic agonists
• epilepsy or seizure disorder
• hyperthyroidism
• chronic corticosteroid use
• those taking monoamine oxidase inhibitors or Tricyclic antidepressants for depression
• hypersensitivity to albuterol or any of its' delete components
• pregnancy

• use of ergogenic aids or supplements with anabolic characteristics including, but not limited to:

  • creatine monohydrate
  • anabolic steroids (e.g., testosterone)
  • growth hormone and their analogs and/or derivatives

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Arm 1; group of persons with spinal cord injury will receive blinded placebo capsule	Drug: placebo; An ambiguous sheathing capsule will be placed over a lactose placebo pill. The placebo will have no effect on pulmonary function.
Experimental: Arm 2; group of persons with spinal cord injury will receive blinded beta-2 adrenergic agonist capsule	Drug: extended release beta-2 adrenergic agonist; Albuterol extended release belongs to a class of drugs known as bronchodilators. It works in the airways by opening breathing passages and relaxing muscles.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Inspiratory Respiratory Muscle Strength	Respiratory muscle strength as measured by maximal inspiratory and pressures at the mouth.	Outcome will be measured at baseline, prior to intervention, and after 12 weeks of twice daily drug treatment.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Expiratory Respiratory Muscle Strength	Respiratory Muscle Strength defines as Maximal expiratory muscle strength at the mouth.	Outcome will be measured at baseline, prior to intervention, and after 12 weeks of twice daily drug treatment.

Collaborators and Investigators

• Sponsor: US Department of Veterans Affairs
• Investigators: Principal Investigator: Greg Schilero, MD, VA Medical Center, Bronx

Study record dates

Study Major Dates

• Study Start: April 1, 2007
• Primary Completion (Actual): August 1, 2012
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: September 15, 2008
• First Submitted That Met QC Criteria: September 16, 2008
• First Posted (Estimate): September 18, 2008

Study Record Updates

• Last Update Posted (Estimate): March 17, 2015
• Last Update Submitted That Met QC Criteria: February 24, 2015
• Last Verified: February 1, 2015

More Information

Terms related to this study

• Keywords: spinal cord injury; beta-2 agonist; respiratory muscle strength; pulmonary function test
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Spinal Cord Diseases; Wounds and Injuries; Spinal Cord Injuries; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Adrenergic Agonists; Adrenergic Agents
• Other Study ID Numbers: B4162-C

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No